GB2590943A

GB2590943A - A collection container

Info

Publication number: GB2590943A
Application number: GB2000228.3A
Authority: GB
Inventors: Ryder Martyn
Original assignee: Solo Containment Ltd
Current assignee: Solo Containment Ltd
Priority date: 2020-01-08
Filing date: 2020-01-08
Publication date: 2021-07-14
Anticipated expiration: 2040-01-08
Also published as: GB202000228D0; GB2590943B

Abstract

A collection container 10 for collecting micronised pharmaceutical materials comprises an outer gas-impermeable sleeve 70 comprising a HEPA filter 100, and an inner gas-permeable filter sleeve 60. Both sleeves are attached to a connection valve 50. The sleeves may be flexible bags. The outer sleeve may be rigid or comprise polyurethane. The connection valve may be a slide valve. The collection container can be used to retain micronized pharmaceutical material e.g. from a jet mill, with most particles remaining inside the inner sleeve, and the HEPA filter stopping further particles from escaping; thus protecting operators from contaminated air.

Description

A collection container The present invention relates generally to a collection container for collecting micronised pharmaceutical materials and a method of collecting micronised pharmaceutical materials, and finds particular, although not exclusive, utility in protecting operators from exposure to fine particle pharmaceutical materials as airborne contaminants.

Presently, when pharmaceutical materials are micronised using jet mills, such that they have relatively smaller particle sizes, the containment equipment required to protect operators is, by design, bulky to accommodate the range of equipment. This is because typical jet mills, used for micronising the pharmaceutical materials, or other such hazardous material, are arranged such that the micronised phatmaceutical materials are entrained in air and exit the jet mill as an air or gas stream with a high concentration of product particles. The air/gas stream and entrained product may be captured in a filter bag. The filter bag collects the micronised pharmaceutical materials and the air exits through the walls of the filter bag. however, the filter bag does not entrap all of the tine particle migration and some invariably migrates through the filter bag with the air/gas. *to avoid operators from being exposed to the pharmaceutical materials it is typical for large containment, tent-type, enclosures to be erected, within which are installed the jet mill and product recovery filter bags. These are often large, complicated structures which include ports for allowing the untreated pharmaceutical materials to enter the inside of the enclosure. Furthermore, equipment must be used to create a pressure within the enclosure which is slightly less than the ambient pressure outside the enclosure. The enclosures take many hours to set up and, after use, the clean-down operation can take as many hours again. Typically, personnel will also need to wear personal protective equipment during removal of the enclosures which is uncomfortable and time consuming to put on and take off, and therefore increases cost. It would therefore be beneficial to have a quicker, simpler apparatus and method for collecting micronised pharmaceutical materials from jet mills, and other micronisers, whilst at the same time isolating operators from the micronised pharmaceutical materials. ;In a first aspect, the invention provides a collection container for collecting micronised pharmaceutical materials, the collection container comprising an outer sleeve having gas-impermeable walls and an inner filtration sleeve, the inner sleeve having gas-permeable walls, the outer sleeve comprising a HERA filter at one end thereof, the collection container comprising a connection valve, both the inner and outer sleeves sealably attached to the connection valve, the connection valve arranged for connection to a microniser, the collection container arranged such that in use with the connection valve connected to a microniser, micronised pharmaceutical materials entrained in air enter the inner sleeve via the connection valve, the air exits the collection container through the HEPA filter after passing through the gas-permeable walls of the inner sleeve, the majority of the micronised pharmaceutical materials remaining inside the inner sleeve being prevented from exiting the inner sleeve by the gas-permeable walls, with any micronised pharmaceutical materials having passed through the walls of the inner sleeve into the outer sleeve being retained within the outer sleeve and prevented from exiting the outer sleeve by the gas-impermeable walls and the HEPA filter. ;In this way, large enclosures are not required. Instead, a compact container is provided which is relatively quick and simple to set up. Any micronised pharmaceutical materials escaping the filter bag will be caught by the outer sleeve. Moreover, after micronising the pharmaceutical materials, the connection valve can be closed and the collection container connected to drums, bags, or other final containers, for onward transport of the micronised pharmaceutical materials. The collection container may then be reused, if the same pharmaceutical materials are to be micronised again, or disposed of if a non-compatible, or new material, is to be micronized. In this sense the collection container is disposable and could be described as "single-use". ;The inner sleeve may be a flexible filter bag. Likewise, the outer sleeve may be a flexible bag. Alternatively, a rigid outer sleeve may be employed. The outer sleeve may comprise a suitable gas impermeable material such as polyurethane. The outer sleeve may be flexible. The inner and/or outer sleeve may comprise film material. ;The connection valve may be a slide connection valve. The slide connection valve may be arranged (interlocked) to open and close simultaneously with another slide connection valve located on the microniser. The connection valve may be initially attached to the inner sleeve. The connection valve may include a neck member with the inner sleeve. The outer sleeve may include an aperture through which the neck member projects. The outer sleeve may be sealed around this neck member. The sealing may be effected by means of a clamp system. ;The outer sleeve may include a sealable side opening for inserting the inner sleeve inside the outer sleeve. The sealable side opening may include a fastener which locks together the two edges by means of corresponding teeth and a sliding tab. Other types of scalable fasteners are contemplated. ;The inner sleeve may be co-axial with the outer sleeve. The width of the outer sleeve may be in the range of 1.2 to 2.5 times the width of the inner sleeve. ;in a second aspect, the invention provides a method of collecting micronised pharmaceutical materials, the method comprising the steps of: a) providing a collection container according to the first aspect; b) attaching the connection valve to a microniser; c) opening the connection valve; d) operating the microniser to micronise pharmaceutical materials and emit them entrained in air via the connection valve into the inner sleeve such that the air exits the outer sleeve via the HEPA filter after passing through the gas-permeable walls of the inner sleeve, the majority of the micronised pharmaceutical materials remaining inside the inner sleeve, being prevented from exiting the inner sleeve by the gas-permeable walls, with any micronised pharmaceutical materials having passed through the walls of the inner sleeve into the outer sleeve, being retained within the outer sleeve and prevented from exiting the outer sleeve by the HEPA filter. ;the method may further comprise the steps of: a) stopping the microniser; b) closing the connection valve; c) removing the collection container; d) attaching it to a final container; e) opening the connection valve and transferring the micronised pharmaceutical materials to the final container; 0 closing the connection valve; g) disposing of the collection container. ;*the microniser may be a jet mill or other particle size reduction device, the term "micronised materials" may include powdered materials The above and other characteristics, features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawing, which illustrate, by way of example, the principles of the invention. This description is given for the sake of example only, without limiting the scope of the invention. The reference figure quoted below refers to the attached drawing.

Figure 1 is schematic view of a collection container in conjunction with a jet mill. The present invention will be described with respect to certlin drawings but the invention is not limited thereto but only by the claims. the drawings described are only schematic and are non-limiting. Each drawing may not include all of the features of the invention and therefore should not necessarily be considered to be an embodiment of the invention. In the drawings, the size of some of the elements may be exaggerated and not drawn to scale for illustrative purposes. The dimensions and the relative dimensions do not correspond to actual reductions to practice of the invention.

Furthermore, the terms first, second, third and the like in the description and in the claims, are used for distinguishing between similar elements and not necessarily for describing a sequence, either temporally, spatially, in ranking or in any other manner. it is to be understood that the terms so used are interchangeable under appropriate circumstances and that operation is capable in other sequences than described or illustrated herein. Likewise, method steps described or claimed in a particular sequence may be understood to operate in a different sequence.

Moreover, the terms top, bottom, over, under and the like in the description aiad the claims are used for descriptive purposes and not necessarily for describing relative positions. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that operation is capable in other orientations thaia described or illustrated herein.

It is to be noticed that the term "comprising", used in the claims, should not be interpreted as being restricted to the means listed thereafter; it does not exclude other elements or steps. it is thus to be interpreted as specifying the presence of the stated features, integers, steps or components as referred to, but does not preclude the presence or addition of one or more other features, integers, steps or components, or groups thereof Thus, the scope of the expression "a device comprising means A and B" should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the only relevant components of the device are A and B. Reference throughout this specification to "an embodiment" or "an aspect" means that a particular feature, structure or characteristic described in connection with the embodiment or aspect is included in at least one embodiment or aspect of the present invention. Thus, appearances of the phrases "in one embodiment", "in an embodiment", or "in an aspect" in various places throughout this specification are not necessarily all referring to the same embodiment or aspect, but may refer to different embodiments or aspects. Furthermore, the particular features, structures or characteristics of any one embodiment or aspect of the invention may be combined in any suitable manner with any other particular feature, structure or characteristic of another embodiment or aspect of the invention, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments or aspects.

Similarly, it should be appreciated that in the description various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Moreover, the description of any individual drawing or aspect should not necessarily be considered to be an embodiment of the invention. Rather, as the following claims reflect, inventive aspects lie in fewer than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention.

Furthermore, while some embodiments described herein include some features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form yet further embodiments, as will be understood by those skilled in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

Tn the description provided herein, numerous specific details arc set forth.

However, it is understood that embodiments of the invention may be practised without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

In the discussion of the invention, unless stated to the contrary, the disclosure of alternative values for the upper or lower limit of the permitted range of a parameter, coupled with an indication that one of said values is more highly preferred than the other, is to be construed as an implied statement that each intermediate value of said parameter, lying between the more preferred and the less preferred of said alternatives, is itself preferred to said less preferred value and also to each value lying between said less preferred value and said intermediate value.

The use of the term "at least one" may mean only one in certain circumstances.

The use of the term "any" may mean "all" and/or "each" in certain circumstances.

The principles of the invention will now be described by a detailed description of at least one drawing relating to exemplary features. It is clear that other arrangemen can be configured according to the knowledge of persons skilled in the art without departing from the underlying concept or technical teaching, the invention being limited only by the terms of the appended claims.

Figure 1 is a schematic view of a collection container 10 connected to a jet mill 20. In detail, the jet mill 20 includes an outlet port 30. This port includes a slide connection valve 40 for co-operation with a removably attachable corresponding slide connection valve.

The collection container 10 comprises such a slide connection valve 50 located at the end of a neck-80. Sealably attached to the neck 80 is an inner sleeve 60 including gas-permeable walls. The inner sleeve 60 has no openings other than the neck 80 and the pores in the -walls.

Also sealably connected to the neck 80 is an outer sleeve 70 having gas-impermeable walls.

The outer sleeve 70 has two openings, one at each end. One opening is co-axially placed around the neck and sealed to the neck by a clamp band 90. The, axially opposed, other opening is sealed to a HER& filter 100.

The various features around the neck 80 in Figure 1 are shown slightly separated from one another to improve the clarity of the drawing.

In use, with the two slide connection valves 40, 50 attached to one another and opened, the jet mill is in fluid connection with the interior of the inner sleeve 60. Micronised pharmaceutical materials entrained in air (or any other suitable gas) will exit the port 30 and enter the interior of the inner sleeve 60. The air will pass through the walls of the inner sleeve leaving behind the micronised pharmaceuticals (not shown). 't he air will pass into the interior of the outer sleeve 70. The air will then exit via the HEM filter 100. Any micronised pharmaceutical materials which passes through the inner sleeve walls will not exit the outer sleeve because the TTEPA filter will prevent that from occurring

Claims

CLAIMSA collection container for collecting rnicronised pharmaceutical materials, the collection container comprising an outer sleeve having gas-impermeable walls and an inner filter sleeve having gas-permeable walls, the outer sleeve comprising a 1-11LPA filter at one end thereof, the collection container comprising a connection valve, both the inner and outer sleeves sealably attached to the connection valve, the connection valve arranged for connection to a microniser, the collection container arranged such that in use with the connection valve connected to a microniser, micronised pharmaceutical materials entrained in air enter the inner sleeve via the connection valve, the air exits the collection container through the HER:\ filter after passing through the gas-permeable walls of the inner sleeve, the majority of the micronised pharmaceutical materials remaining inside the inner sleeve being prevented from exiting the inner sleeve by the gas-permeable walls, with any micronised pharmaceutical materials having passed through the walls of the inner sleeve into the outer sleeve being retained within the outer sleeve and prevented from exiting the outer sleeve by the gas-impermeable walls and the FIEPA filter.
2. the collection container of claim 1, wherein the inner sleeve is a flexible filter bag.
3. The collection container of either one of claims 1 and 2, wherein the outer sleeve is a flexible bag.
4. The collection container of claim 3 wherein the outer sleeve comprises polyurethane.
5. The collection container of any preceding claim, wherein the connection valve is a slide connection valve.
6. the collection container of any preceding claim, wherein the outer sleeve includes a sealable side opening for inserting the inner sleeve inside the outer sleeve.
7. A method of collecting micronised pharmaceutical materials, the method comprising the steps of: ej providing a collection container according to any preceding claim; 0 attaching the connection valve to a microniser; g) opening the connection valve; h) operating the microniser to micronise pharmaceutical materials and emit them entrained in air via the connection valve into the inner sleeve such that the air exits the outer sleeve via the HEPA filter after passing through the gaspetmeable walls of the inner sleeve, the majority of the micronised pharmaceutical materials remaining inside the inner sleeve being prevented from exiting the inner sleeve by the gas-permeable walls, with any micronised pharmaceutical materials having passed through the walls of the inner sleeve into the outer sleeve being retained within the outer sleeve and prevented from exiting the outer sleeve by the gas-impermeable walls and the HERA filter.
8. The method of claim 7, further comprising the steps of: h) stopping the microniser; ij closing the connection valve; jj removing the collection container; k) attaching it to a final container; 1) opening the connection valve and transferring the micronised pharmaceutical materials to the final container; m) closing the connection valve; n) disposing of the collection container.